Menu
IMBRUVICA® side effects for cGVHD IMBRUVICA® side effects for cGVHD

Understanding IMBRUVICA® Treatment

Understanding Possible Side Effects of IMBRUVICA® (ibrutinib)

 

IMBRUVICA® may cause serious side effects, including bleeding problems, infections, decrease in blood cell counts, heart rhythm problems (atrial fibrillation and atrial flutter), high blood pressure (hypertension), second primary cancers, and tumor lysis syndrome (TLS)1.

The most common side effects in the chronic graft versus host disease (cGVHD) clinical trial were1:

  • Tiredness

  • Muscle spasms

  • Bruising

  • Nausea

  • Diarrhea

  • Bleeding (Hemorrhage)

  • Low platelet counts

  • Low red blood cell count

  • Mouth sores (stomatitis)

  • Pneumonia

In the cGVHD clinical trial nearly 1 in 4 of patients stopped taking IMBRUVICA® because of side effects.1

This is not a complete list of side effects. Others may occur. Tell your doctor if you think you are experiencing side effects.

If you are having some side effects, your doctor may tell you to take fewer pills per day or to stop taking IMBRUVICA®. That’s one reason it’s so important to tell your healthcare team about side effects at any point in your treatment.1

 

Helpful tips for cGVHD patients taking IMBRUVICA®

 

You may experience side effects while taking IMBRUVICA®.1 The suggestions below may help you while on IMBRUVICA®. Talk to your healthcare provider if you think you are experiencing any side effects.

 

Tips to help with diarrhea2:

Diarrhea can be an uncomfortable side effect for patients taking IMBRUVICA®. It can also be a sign your cGVHD is getting worse.3 So be sure to contact your doctor right away if you develop this symptom. In the meantime, there are also some tips that can help you manage your condition:

  • Stay hydrated. Drink fluids such as water, decaffeinated tea, and clear broth

  • Eat small meals often, and avoid very hot or spicy foods

  • Avoid greasy foods, bran, raw fruits and vegetables, and caffeine

  • Avoid alcohol and drinks with caffeine

 

To help reduce tiredness4:

 
  • Balance periods of light movement with periods of rest

  • Get plenty of sleep, which may include short naps

  • Remain well hydrated throughout the day

  • Eat a well-balanced diet that includes protein

 

To help prevent infection5:

 
  • Wash hands often and bathe every day

  • Avoid crowds and individuals with contagious diseases

  • Do not keep fresh flowers or live plants in your living space

  • Do not clean droppings from your pets; have someone do this for you

Infection is a serious possible side effect of IMBRUVICA®. Notify a healthcare professional immediately if signs of infection (eg, fever, chills, weakness, and confusion) occur.1

 

References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2017. 2. American Cancer Society. Getting help with diarrhea. https://www.cancer.org/content/dam/cancer-org/cancer-control/en/booklets-flyers/getting-help-for-diarrhea-english.pdf. Accessed August 17, 2017. 3. Choi SW, Levine JE, Ferrara JL. Pathogenesis and management of graft versus host disease. Immunol Allergy Clin North Am. 2010;30(1):75-101. 4. American Cancer Society. Managing cancer-related fatigue at home. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/fatigue/managing-fatigue-at-home.html. Accessed August 17, 2017. 5. American Cancer Society. Preventing infections in people with cancer. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/infections/preventing-infections-in-people-with-cancer.html. Accessed August 17, 2017.

 

You are now leaving www.imbruvica.com

By clicking "OK" below you will be taken to a website that may contain links or references to other websites to which our Privacy Policy may not apply. We encourage you to read the Privacy Policy of every website you visit.

For any questions about the Pharmacyclics Privacy Policy, please visit www.pharmacyclics.com.

OK
Cancel
 

Are you a healthcare professional?

You are leaving the patient and caregiver site and entering the US Healthcare professional site. The information contained in this site is intended for US healthcare professionals only. Click “OK” below if you are a healthcare professional.

OK
Cancel
+

IMPORTANT SIDE EFFECT INFORMATION

Before taking IMBRUVICA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA® for any planned medical, surgical, or dental procedure
  • have bleeding problems
  • have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes
  • have an infection
  • have liver problems
  • are pregnant or plan to become pregnant. IMBRUVICA® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA®
    • Females should not become pregnant during treatment and for 1 month after the last dose of IMBRUVICA®
    • Males should avoid getting female partners pregnant during treatment and for 1 month after the last dose of IMBRUVICA®
  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA® or breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA® with certain other medicines may affect how IMBRUVICA® works and can cause side effects.

How should I take IMBRUVICA®?

  • Take IMBRUVICA® exactly as your healthcare provider tells you to take it
  • Take IMBRUVICA® 1 time a day
  • Swallow IMBRUVICA® capsules and tablets whole with a glass of water
  • Do not open, break, or chew IMBRUVICA® capsules
  • Do not cut, crush, or chew IMBRUVICA® tablets
  • Take IMBRUVICA® at about the same time each day
  • If you miss a dose of IMBRUVICA® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA® at your regular time on the next day. Do not take extra doses of IMBRUVICA® to make up for a missed dose
  • If you take too much IMBRUVICA®, call your healthcare provider or go to the nearest hospital emergency room right away

What should I avoid while taking IMBRUVICA®?

  • You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA®. These products may increase the amount of IMBRUVICA® in your blood

What are the possible side effects of IMBRUVICA®?

IMBRUVICA® may cause serious side effects, including:

  • Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA® and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time
  • Infections can happen during treatment with IMBRUVICA®. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA®
  • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA®, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts
  • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter). Serious heart rhythm problems and death have happened in people treated with IMBRUVICA®, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint
  • High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA®. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure
  • Second primary cancers. New cancers have happened during treatment with IMBRUVICA®, including cancers of the skin or other organs
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

The most common side effects of IMBRUVICA® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL)  include:

  • Diarrhea

  • Bruising

  • Muscle and bone pain

  • Tiredness

  • Rash

  • Fever

  • Nausea

 

The most common side effects of IMBRUVICA® in adults with cGVHD include:

  • Tiredness

  • Bruising

  • Diarrhea

  • Mouth sores (Stomatitis)

  • Muscle spasms

  • Nausea

  • Pneumonia

  • Tiredness

  • Mouth sores (Stomatitis)

  • Pneumonia

  • Bruising

  • Muscle spasms

  •  

  • Diarrhea

  • Nausea

 

Diarrhea is a common side effect in people who take IMBRUVICA®. Drink plenty of fluids during treatment with IMBRUVICA® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

General information about the safe and effective use of IMBRUVICA®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA® for a condition for which it was not prescribed. Do not give IMBRUVICA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA® that is written for health professionals.

Please see the full Important Product Information.

INDICATIONS

What is IMBRUVICA® (ibrutinib)?

IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with:

  • Mantle cell lymphoma (MCL) who have received at least one prior treatment
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
  • Waldenström's macroglobulinemia (WM)
  • Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment
  • Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy 

It is not known if IMBRUVICA® is safe and effective in children.


Your use of the information on this site is subject to the terms of the Legal Notice and new Privacy Policy of Pharmacyclics LLC. This site is published by Pharmacyclics LLC which has developed the content in conjunction with Janssen Biotech, Inc. Any information that is collected on this site may be shared between Pharmacyclics LLC and Janssen Biotech, Inc. This information is intended for use by our customers, patients, and healthcare professionals in the United States and Puerto Rico only. Pharmacyclics LLC recognizes that the Internet is a global communication medium; however laws, regulatory requirements, and medical practices vary from country to country.

IMBRUVICA® (ibrutinib) is covered by U.S. Patents, which are listed in FDA's Orange Book (available at https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm).

© Pharmacyclics LLC 2018

© Janssen Biotech, Inc. 2018

04/18 PRC-04032